Scientific Advice and Regulatory Support Services at BfArM

Overview of Advice Services

BfArM provides comprehensive scientific and regulatory advice to support the development and authorisation of medicinal products in Germany. These services help applicants address scientific, quality, non-clinical, clinical, and procedural questions early in development, reducing risks and streamlining regulatory pathways. Advice is available for both human and veterinary medicines where BfArM is competent. Advice - BfArM

Pre-Submission Scientific Advice

• Formal scientific advice meetings before submitting marketing authorisation or clinical trial applications.
• Covers questions on quality (CMC), non-clinical, clinical development plans, paediatric requirements, orphan designation, and benefit-risk considerations.
• Applicants submit a briefing document; BfArM provides written advice and holds face-to-face or virtual meetings.
• Advice is non-binding but highly influential for subsequent submissions.

Innovation Office and Early Access Support

• The Innovation Office serves as a central point for innovative medicines, advanced therapies (ATMPs), and novel technologies.
• Offers early dialogue on regulatory strategy, classification (e.g., ATMP vs. non-ATMP), and support for breakthrough therapies.
• Coordinates with EMA Innovation Task Force (ITF) when needed for EU-level advice.

Orphan Medicinal Product Designation

• BfArM supports national applications for orphan designation in Germany.
• Advice includes prevalence assessment, medical plausibility, and significant benefit justification.
• Coordinates with EMA for EU orphan designation where applicable.

Paediatric Investigation Plans (PIP) and Deferrals

• Guidance on paediatric development requirements under EU Paediatric Regulation.
• Support for PIP submissions, waivers, deferrals, and compliance statements.
• Advice on paediatric study design and extrapolation strategies.

Clinical Trial and Authorisation Guidance

• Advice on clinical trial applications (CTA) under national or EU CTR processes.
• Support for investigator-initiated trials, substantial modifications, and end-of-trial notifications.
• Regulatory guidance on GMP, GCP, and pharmacovigilance requirements.

Practical Aspects

• Requests for advice are submitted electronically via BfArM portal with specified templates.
• Fees apply based on complexity and meeting format.
• BfArM encourages early engagement to align development with regulatory expectations.

These advice services at BfArM aim to foster innovation, ensure high-quality applications, and accelerate patient access to safe and effective medicinal products in Germany and the EU. Advice - BfArM